James C. Shehan

James C. Shehan, Chair of Lowenstein’s FDA Regulatory Practice, is quoted extensively in an article published by the Regulatory Affairs Professionals Society that summarizes an expert panel discussion on The Orphan Drug Act at BIO Digital 2020. Noting that the definition of an orphan drug has not changed since the law passed in 1983, he says that “[s]ince the passage of the act there’s been a steady rise in products that are designated by the FDA as orphan drugs and that ultimately are approved and reach the market.” Shehan mentions a 2018 Government Accountability Office that found “more could be done to bring rare disease drugs to market,” and that the Tax Cuts and Jobs Act of 2017 reduced the orphan drug tax credit from 50 percent to 25 percent. The panel at BIO Digital included Nick Leschly, CEO of Bluebird Bio; Laura Clague, CFO of Retrophin, Inc.; Natasha Bonhomme, Chief Strategy Officer of the Genetic Alliance; and Bonnie Schneider, Director of the IgAN Foundation.